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The 9 crucial steps of weighing risks and benefits in PSURs


February, 2019

Now that you’ve identified and described all the risks that show up linked to the substance or medicine, it is time to put them into the context of their benefits. Otherwise, there wouldn’t be any perspective on whether the medicinal product is worth risking all the side-effects we’ve listed.

Analyzing the impact of both risks and benefits can give interesting insights to you, your client and the capable authorities you report to.

In day-to-day pharmacovigilance, it becomes easy for us to focus on risks, as our job is to prevent them in any way we can.

But we can’t lose sight of the importance of benefits. We always have to think about risks through the meaning they have for their consumers, and in what way do the benefits of a medicine outshine risks for a patient’s quality of life.

I. The importance of the risk-benefit analysis

In the PSUR section of Risk-benefit analysis, you delve into the relationship between the beneficial effects of a substance and the risks that were expected or reported.

In a way, this is the main reason we write these reports, why our jobs exist. This analysis tells us, other medical professionals, and the general public why is a certain medicine worth risking the ADRs you’ve previously listed in the PSUR.

Any new information on the product’s effects are reviewed here in detail, and put into a larger context with any other possible effect they have, and measured against the indications they are prescribed for.

Why weighing risks and benefits in post-authorization matters

Before being put on the market, every medicinal product goes through extensive clinical trials that determine its effects, both beneficial and adverse. However, no matter how extensive or detailed the trials, the information they show cannot come close to the information we receive in post-authorization monitoring.

The main reason is that the population a product is tested on during clinical trials will always be significantly smaller and less diverse than the population that consumes the product once it arrives on the market. This makes rare adverse effects harder to detect during clinical trials. In many cases they become visible only when monitored in post-authorization.

Another important difference is that the use of the product during trials is always under strictly controlled conditions. There are foolproof protocols that ensure the usage of the product is always by the book. Once the product comes into contact with a larger public, professional control has less reach, potentially increasing the chance of misuse, medication errors, off-label use and other deviations from the required dosage or prescribed use.

Our knowledge of medicinal products and substances grows constantly with every new study and report. Our insight into risks and benefits can change significantly over the years.

That is why we need to evaluate risks and benefits continuously. As time goes by, authorized medicinal products will have a growing number of patients that consume them, and with them, a more comprehensive pool of data that will make it easier for us to understand fully the impact of a substance. By understanding this, we make sure that patients are treated properly and that unwanted effects are avoided whenever possible.

II. Writing the risk-benefit analysis in PSUR

As various studies are conducted and cases are reported, we get more and more information to interpret in PSURs. Through continuous monitoring of literature, we gather more data that expands on what we already have accumulated. To give regulatory authorities the full picture, our analyses have to display and argument our conclusions and insights in the right way.

Describe the medicine in general

First of all, we define what the medicinal product is, how is it used and what is it used for. Note all of its indications. In what way does it affect them? With what intensity? What is the medicine’s success rate? We display the most important information at the start, then go into detail.

When working in Sympto®, you can easily find all of this information collected under the Products and Clients modules. Just enter the substance or medicinal product you’re working on in the search, and find all relevant information.

Check the Clinical Overview

A substance’s Clinical Overview is the crown document for defining the risk-benefit ratio. It lists the indications for which a substance is used. You can use it to describe every clinical trial related to a substance, and to describe the adverse reactions noted during a trial.

Is your information up to date?

Check with the sites of your competent authorities and see if all the information in the SmPC is aligned with the most current regulations. You have to make sure if the product information is updated.

If you notice any changes, note it in comments on any literature finding or case it could possibly impact. Sympto® will make it easier for you to discuss these changes with your colleagues or just give them a simple heads-up. If you enter these new changes in Sympto®, the system will track them and save a version of the old information so you can look it up any time in the future.

Underline the problem

Think of how it affects the patient’s quality of life. What does this problem mean on a global scale, and what on an individual scale? Look at all the information you’ve found through literature and older reports, group and organize it in Sympto’s filters to get a clearer view of everything you’ve accumulated. Then, answer how does this information influence a single, particular patient, and what does his progress or amelioration mean for healthcare and the health sciences in general.

How do the benefits outweigh the risks?

Point out the benefits of the product in question. Why is it better to risk a headache or nausea than to stop using the medicine in question? Always draw a larger picture and establish the relationship between the risks and benefits of its use.

Consider the patient’s perspective

Look at the risks and benefits from the perspective of a patient. The history of a patients illness also holds significance in regards to this assessment. In Sympto’s Cases module, you can find detailed information on the patients and their drug history to more easily pinpoint what does a product’s safety profile mean for them.

Take a look at the big picture

After considering its impact on the individual, broaden your view to a global scale. What do these risks and benefits mean to healthcare in general? What do they mean to whole populations of patients? What do they mean for further research or clinical trials?

Compare the medicine with others

Risk-benefit assessments are never an isolated calculation. You always put them into context with other medicinal products with similar indications, or lack of treatment. How does the risk-benefit balance of your medicinal product correlate to the risk-benefit of other medicine from the same class, or other medicine’s used for the same indications? This comparison could give you valuable information on the efficiency or efficacy of a certain product.

Balance it out – is it beneficial?

You conclude the analysis by pointing out why exactly is the benefit bigger the risk. If you’ve found such information in your monitoring, state the number of patients that were ameliorated or recuperated thanks to the medicine you monitor. Everything comes down to the conclusion that the goal of the product and the analysis is to enhance both the life quality of patients, and health in general.

The conclusion of the risk-benefit analysis is sometimes the single most important line in the report. However, there are many other sections that determine their quality. To read about writing other parts of PSURs, check out our articles on identifying risks and the literature section.

Feel free to ask more about this topic.
And if you want to know more about Sympto®, we invite you to

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